New FDA-Guidance for Industry draft on AI

In January 2025, the U.S. Food and Drug Administration (FDA) published a draft Guidance for Industry and other interested parties entitled 'Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products'. This draft provides recommendations for 'sponsors' and other interested parties on the use of artificial intelligence (AI) to support regulatory decisions regarding the safety, efficacy or quality of medicinal products.

A key element of the draft is the introduction of a risk-based approach to assess the credibility of AI models. This approach is intended to help establish and assess confidence in the performance of an AI model for a specific context of use (COU). The guideline emphasises the importance of a clearly defined context of use for each AI model, as this forms the basis for the evaluation of the model.

The risk-based approach comprises seven steps:

• Step 1: Define the question of interest.
• Step 2: Define the context of use for the AI model.
• Step 3: Assess of the AI model risk.
• Step 4: Develop of a plan to establish AI model credibility within the context of use.
• Step 5: Execute the plan.
• Step 6: Document the results of the credibility assessment plan and discuss deviations from the plan.
• Step 7: Determine the adequacy of the AI model for the content of use.

The guide also emphasises the importance of continuous monitoring and maintenance of AI models to ensure that they remain reliable throughout their use. This includes regularly assessing model performance and documenting any changes that could affect the model's output.
The FDA encourages sponsors to contact the agency early in the process to address questions about assessing the credibility of AI models or the use of AI in drug development. Public comments on this draft can be submitted until 7 April 2025 to ensure they are considered in the final development of the guidance.

Source: Guidance for Industry and Other Interested Parties 'Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products'